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SC MEDICA

France · Strasbourg Bas-Rhin
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Australia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 0Class III 0unclassified 1
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
7registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 3 510(k), 0 PMA, 13 excluded
Brazil0 confirmed, 4 excluded
Saudi Arabia7 confirmed, 0 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: SC MEDICA

Company information

Country
France
City
Strasbourg Bas-Rhin

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12024 · K232468
22025 · K250679

FDA listed device types

Orthopedic Manual Surgical Instrument 1System, Facet Screw Spinal Device 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250679FFX Facet Fixation System2025-12-04
USK252153FFX Facet Fixation System2025-10-16
USK232468SC Medica FFX2024-05-09
SAME0000007413SFDAA00004FFX ancillary instruments—
SAME0000007413SFDAA00003FFX ancillary instruments—

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